Ankara Bilkent City Hospital Pain Medicine
Ankara, Turkey (Türkiye)
NCT Number: NCT06748469
Brief Summary:
This study aims to compare the efficacy of short-duration (240 sec) and long-duration (480 sec) pulsed radiofrequency (PRF) applications on pain, functionality, patient satisfaction, and side effect profiles in patients with lumbosacral radicular pain. The PRF procedure will be applied to the dorsal root ganglion (DRG) under fluoroscopic guidance.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Ankara, Turkey (Türkiye)
In this study, all procedures will be performed in the prone position under sterile conditions and guided by fluoroscopy. After identifying anatomical landmarks, the cannula will be positioned close to the dorsal root ganglion. The tip of the cannula will be placed in the dorsal-cranial quadrant of the intervertebral foramen in the lateral view, and between one-third and halfway along the pedicle column in the anteroposterior view. Once the RF cannula is properly positioned, an RF electrode will be inserted through the cannula and connected to the RF generator. The final position of the RF cannula will be confirmed by sensory stimulation (paresthesia) at less than 0.5 V and motor stimulation perceived at a level at least 1.5 times greater than the sensory stimulation threshold.
In the short-duration PRF group, a PRF cycle will be applied at 42°C for 240 seconds, while in the long-duration group, it will be applied at 42°C for 480 seconds. Following the PRF application, epidural spread will be confirmed using contrast dye, after which 4 mL of a solution containing 8 mg dexamethasone and 5 mg bupivacaine will be injected at each level.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Age ≥ 18 years
Dorsal Root Ganglion pulsed radiofrequency 240sec
The duration of the intervention will be 480 seconds
Time frame: 1, 3, and 6 months
Change in pain severity
Time frame: 1, 3, and 6 months
Change in GPE scores according to the 7-point Likert scale (1=worst, 7=best) over time will be used to assess patient satisfaction and improvement
Time frame: 0, 1, 3, and 6 months
Change in 10-item Oswestry disability index (ODI) questionnaire (range: 0-100; 0 = no disablility) over time will be used to assess physical function
Time frame: 1, 3, and 6 months
Change in Patient satisfaction (5-point Likert scale, 0= very disappointed, 5=very satisfied) over time will be used
Time frame: 1, 3, and 6 months
Change in analgesic use over time (0=same, 1=decreased, 2=increased)
Ankara City Hospital Bilkent
Other
Analgesic Efficacy of Different Pulse Radiofrequency Treatment Durations in the Management of Lumbosacral Radicular Pain
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07193758
Disc Herniation With Radiculopathy, Fusion of Spine, Lumbar Region
Leuven, Belgium
View Trial DetailsNCT07535476
Disc Disease, Neck Pain
Mersin, Ciftlikkoy, Turkey (Türkiye)
View Trial DetailsNCT00189605
Radicular Pain
Scottsdale, Arizona, United States
View Trial DetailsNCT01205464
Cognition Disorders, Cognitive Dysfunction
Linköping, Östergötland County, Sweden
View Trial Details